Diseased mitral and tricuspid valves frequently need replacement or repair. The mitral and tricuspid valve leaflets or supporting chordae may degenerate and weaken or the annulus may dilate leading to valve leak. Mitral and tricuspid valve replacement and repair are frequently performed with aid of an annuloplasty ring, used to reduce the diameter of the annulus, or modify the geometry of the annulus in any other way, or aid as a generally supporting structure during the valve replacement or repair procedure. Such annuloplasty rings or other annuloplasty implants or cardiac valve implants in general such as replacement valves, are put into position by various tools.
An assembly for holding an annuloplasty ring in place for placing a suture line and attach the ring to the annulus tissue is disclosed in U.S. Pat. No. 6,197,052. The annuloplasty ring or suture guide is releasably attached to a guide mount by sutures or threads passing through apertures disposed in the guide mount and through the ring. Once the surgeon is ready to release the ring, the sutures for fixing the ring to the mount are cut of at various locations of the mount, and the guide can subsequently be retrieved. The mount is attachable to a handle assembly which is mounted by inserting a cylindrical hub of the handle assembly into a plug of the mount.
United states patent application US2003176916 discloses a holder for an annuloplasty prosthesis having a first component, around which the prosthesis is mounted and a second component, releasably secured to the first component by sutures. Projections align the two holder components to each other, and a further rectangular projection at the second component is required to prevent deformation and reduction of the circumference of the first holder component which is an open ring. I.e. the first holder component can not satisfactory hold the prosthesis without the second holder component. In some embodiments, rather than retaining the prosthesis to the holder by means of sutures passing through the prosthesis, the prosthesis is retained by means of downwardly extending penetrating members such as barbs, pins, pegs, or needles.
Hence, a problem with prior art devices is the risk of damaging the implant due to complicated mechanisms for attachment and detachment to the holder, thereby increasing the amount of manipulation of the implant both during the positioning phase and during repositioning, which may lead to unnecessary wear and risk of damages to the implant.
During heart surgery, a premium is placed on reducing the amount of time used to replace and repair valves as the heart is frequently arrested and without perfusion. A problem with prior art devices is the time consuming attachment or detachment of the annuloplasty device, also referred to as the cardiac valve implant, or simply implant below, to the holder assembly, e.g. by using sutures. It would therefore be very useful to have a medical device for holding the implant to be positioned at the annulus that can be quickly attached or detached to such implant.
If repositioning of the cardiac valve implant becomes necessary it is also critical that the holder can engage the implant easily and quickly. The suture attachment in prior art devices is complicated and time consuming when such repositioning is required.
Another problem with prior art devices is insufficient visibility through the holder and into the annulus due to complex holder construction with elements extending across the annulus and thereby obscuring the sight. Reduced visibility makes accurate positioning more complicated and time consuming with potentially increased risk.
A further problem with prior art devices is insufficient maneuverability of the cardiac valve implant due to lack of freedom of movement between the holder and the delivery tool. Such lack of flexibility also increases the time of the replacement or repair procedure.
Another problem with prior art holders is the limited ability to adapt to implants having a wide range of sizes. It is therefore necessary to have a number of various holders which complicates the procedure further as frequent exchange of holders may be necessary to find the correct fit.
The above problems may have dire consequences for the patient and the health care system. Patient risk is increased.
Hence, an improved medical device for holding a cardiac valve implant would be advantageous and in particular allowing for increased flexibility, reducing the time of lengthy surgery procedures, cost-effectiveness, and increased patient safety. Also, a method of holding a cardiac valve implant with such medical device and a kit comprising a tool for manipulation of such medical device would be advantageous.